Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection

This study has been completed.
Sponsor:
Collaborators:
U.S. Air Force Office of the Surgeon General
Emergency Medicine Foundation
Information provided by (Responsible Party):
Gillian Schmitz, Wilford Hall Medical Center
ClinicalTrials.gov Identifier:
NCT00822692
First received: January 13, 2009
Last updated: December 17, 2015
Last verified: December 2015
  Purpose
Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess.

Condition Intervention
Abscess
Methicillin-Resistant Staphylococcus Aureus Infection
Drug: Trim/ Sulfa DS
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Double Blind, Placebo-Controlled Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection on 30 Day Recurrence Rates.

Resource links provided by NLM:


Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:
  • Recurrence Rates of Abscesses [ Time Frame: 30 days after incision and drainage ] [ Designated as safety issue: No ]
    Number of patient with a new abscess in same or different location as previous lesion


Enrollment: 139
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bactrim DS
Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days
Drug: Trim/ Sulfa DS
bactrim DS (800/160) two tablets PO BID x 7 days
Other Name: Bactrim
Placebo Comparator: matched placebo
matched placebo 2 pills orally (PO) twice a day (BID) x 7 days
Drug: placebo
matched placebo 2 pills PO BID x 7 days

Detailed Description:
All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients age 18-65 who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

  • Patients with diabetes, HIV, cancer or other immunocompromised patients.
  • Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.
  • Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.
  • Patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
  • Finally, patients with sulfa allergy will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822692

Locations
United States, Texas
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
Sponsors and Collaborators
Wilford Hall Medical Center
U.S. Air Force Office of the Surgeon General
Emergency Medicine Foundation
Investigators
Principal Investigator: Gillian R Schmitz Wilford Hall Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gillian Schmitz, Emergency Physician, Wilford Hall Medical Center
ClinicalTrials.gov Identifier: NCT00822692     History of Changes
Other Study ID Numbers: FWH20080055H 
Study First Received: January 13, 2009
Results First Received: July 29, 2009
Last Updated: December 17, 2015
Health Authority: United States: Federal Government

Keywords provided by Wilford Hall Medical Center:
Abscess
Cellulitis
Antibiotics
MRSA

Additional relevant MeSH terms:
Abscess
Infection
Staphylococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Inflammation
Pathologic Processes
Suppuration

ClinicalTrials.gov processed this record on May 26, 2016